Compliance information management of drug registration and research and development entities under the drug marketing authorization holder system
HE Hui
LIU Yi-di
BAN Hao
ZHOU Gang
Abstract：Under the framework of the drug marketing authorization holder system,the systematic collection of compliance information from entities involved in drug registration,research and development(R&D),and manufacture is of paramount significance for regulatory authorities to identify risks and initiate targeted inspection.Building upon the accumulated experience since the implementation of the risk-based registration inspection model,this article,in conjunction with the"Guiding Principles for the Management and Review of Compliance Information for Drug Registration,R&D,and Manufacture Entities(Pilot)",systematically reviewed and analyzed the current regulatory requirements for the compliance management of entities engaged in drug R&D and manufacture activities.It also delved into the requirements for compliance information submission,as well as the review processes and key focus areas employed by regulatory authorities in scrutinizing such compliance information.The objective is to provide a foundation for the scientific utilization of regulatory resources in optimizing the management of compliance information for entities involved in drug R&D and manufacture activities,thereby offering valuable insights for stakeholders.
Keywords：drug marketing authorization holderdrug registrationresearch and developmentand manufacture entitiescompliance information management
Publication Date：2024-08-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1653-1658 )